Teclistamab Approved for Biweekly Dosing in R/R Multiple Myeloma

Johnson & Johnson announced this week that the FDA has approved biweekly dosing for teclistamab (Tecvayli), its bispecific antibody used to treat patients with relapsed or refractory multiple myeloma (MM) who have achieved and maintained a complete response (CR) for at least 6 months. The new approval allows a dosing frequency of 1.5 mg/kg every 2 weeks.

The therapy, given subcutaneously, was first approved in October 2022 for patients who had been treated with at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulator, and an anti-CD38 monoclonal antibody. Teclistamab targets B-cell maturation antigen (BCMA) on MM cells and CD3 on T cells to trigger an immune response.

According to a statement from Johnson & Johnson, teclistamab has been prescribed to more than 3600 patients in the United States since its approval. This latest approval is based results for a group of patients in the phase 1/2 MajesTEC-1 study (NCT03145181, NCT04557098) who were first treated with the recommended phase 2 dose of 1.5 mg/kg once weekly; if patients achieved a CR or better for 6 months or longer (phase 2), they were eligible to reduce dosing frequency to every 2 weeks until their disease progressed or they experience unacceptable toxicity.

“[Teclistamab] is the only BCMA-targeted immune-based therapy with weight-based dosing,” Rachel Kobos, MD, vice president, Oncology Research & Development, Johnson & Johnson Innovative Medicine, said in a statement. “As the first bispecific approved for the treatment of multiple myeloma, combined with the longest in-market experience by physicians, [teclistamab] is another example of our commitment to pioneering cutting-edge research to help improve outcomes for patients with multiple myeloma.”

Adverse events from teclistamab can include cytokine release syndrome and neurologic toxicity, including immune effector cell–associated neurotoxicity syndrome.

Reference

Tecvayli (teclistamab-cqyv) biweekly dosing approved by the US FDA for the treatment of patients with relapsed or refractory multiple myeloma. News release. Johnson & Johnson. February 20, 2024. Accessed February 23, 2024. https://www.jnj.com/media-center/press-releases/tecvayli-teclistamab-cqyv-biweekly-dosing-approved-by-the-u-s-fda-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma